WO2001078737A1 - Medical combinations comprising formoterol and budesonide - Google Patents
Medical combinations comprising formoterol and budesonide Download PDFInfo
- Publication number
- WO2001078737A1 WO2001078737A1 PCT/GB2001/001628 GB0101628W WO0178737A1 WO 2001078737 A1 WO2001078737 A1 WO 2001078737A1 GB 0101628 W GB0101628 W GB 0101628W WO 0178737 A1 WO0178737 A1 WO 0178737A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- pharmaceutical formulation
- pharmaceutically acceptable
- formoterol
- formulation according
- budesonide
- Prior art date
Links
- 229940021598 formoterol and budesonide Drugs 0.000 title abstract description 8
- 239000000203 mixture Substances 0.000 claims abstract description 25
- 239000008194 pharmaceutical composition Substances 0.000 claims abstract description 25
- BPZSYCZIITTYBL-YJYMSZOUSA-N R-Formoterol Chemical compound C1=CC(OC)=CC=C1C[C@@H](C)NC[C@H](O)C1=CC=C(O)C(NC=O)=C1 BPZSYCZIITTYBL-YJYMSZOUSA-N 0.000 claims abstract description 18
- 238000009472 formulation Methods 0.000 claims abstract description 18
- 238000011282 treatment Methods 0.000 claims abstract description 16
- 238000011321 prophylaxis Methods 0.000 claims abstract description 10
- 150000003839 salts Chemical class 0.000 claims description 26
- VOVIALXJUBGFJZ-KWVAZRHASA-N Budesonide Chemical compound C1CC2=CC(=O)C=C[C@]2(C)[C@@H]2[C@@H]1[C@@H]1C[C@H]3OC(CCC)O[C@@]3(C(=O)CO)[C@@]1(C)C[C@@H]2O VOVIALXJUBGFJZ-KWVAZRHASA-N 0.000 claims description 21
- 239000012453 solvate Substances 0.000 claims description 21
- 229960004436 budesonide Drugs 0.000 claims description 20
- 238000000034 method Methods 0.000 claims description 10
- 229940124225 Adrenoreceptor agonist Drugs 0.000 claims description 9
- 239000003246 corticosteroid Substances 0.000 claims description 9
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims description 9
- 230000003110 anti-inflammatory effect Effects 0.000 claims description 7
- OBRNDARFFFHCGE-QDSVTUBZSA-N arformoterol fumarate Chemical compound OC(=O)\C=C\C(O)=O.C1=CC(OC)=CC=C1C[C@@H](C)NC[C@H](O)C1=CC=C(O)C(NC=O)=C1.C1=CC(OC)=CC=C1C[C@@H](C)NC[C@H](O)C1=CC=C(O)C(NC=O)=C1 OBRNDARFFFHCGE-QDSVTUBZSA-N 0.000 claims description 7
- 208000006673 asthma Diseases 0.000 claims description 7
- 239000003937 drug carrier Substances 0.000 claims description 7
- 239000004615 ingredient Substances 0.000 claims description 7
- 239000000546 pharmaceutical excipient Substances 0.000 claims description 7
- 230000001225 therapeutic effect Effects 0.000 claims description 7
- 208000006545 Chronic Obstructive Pulmonary Disease Diseases 0.000 claims description 5
- 201000010099 disease Diseases 0.000 claims description 5
- 206010057190 Respiratory tract infections Diseases 0.000 claims description 4
- 206010062109 Reversible airways obstruction Diseases 0.000 claims description 4
- 208000011479 upper respiratory tract disease Diseases 0.000 claims description 4
- LVGUZGTVOIAKKC-UHFFFAOYSA-N 1,1,1,2-tetrafluoroethane Chemical compound FCC(F)(F)F LVGUZGTVOIAKKC-UHFFFAOYSA-N 0.000 claims description 3
- 241000124008 Mammalia Species 0.000 claims description 3
- 229940121948 Muscarinic receptor antagonist Drugs 0.000 claims description 3
- 239000000812 cholinergic antagonist Substances 0.000 claims description 3
- XWTYSIMOBUGWOL-UHFFFAOYSA-N (+-)-Terbutaline Chemical compound CC(C)(C)NCC(O)C1=CC(O)=CC(O)=C1 XWTYSIMOBUGWOL-UHFFFAOYSA-N 0.000 claims description 2
- YFMFNYKEUDLDTL-UHFFFAOYSA-N 1,1,1,2,3,3,3-heptafluoropropane Chemical compound FC(F)(F)C(F)C(F)(F)F YFMFNYKEUDLDTL-UHFFFAOYSA-N 0.000 claims description 2
- LSLYOANBFKQKPT-DIFFPNOSSA-N 5-[(1r)-1-hydroxy-2-[[(2r)-1-(4-hydroxyphenyl)propan-2-yl]amino]ethyl]benzene-1,3-diol Chemical compound C([C@@H](C)NC[C@H](O)C=1C=C(O)C=C(O)C=1)C1=CC=C(O)C=C1 LSLYOANBFKQKPT-DIFFPNOSSA-N 0.000 claims description 2
- GIIZNNXWQWCKIB-UHFFFAOYSA-N Serevent Chemical compound C1=C(O)C(CO)=CC(C(O)CNCCCCCCOCCCCC=2C=CC=CC=2)=C1 GIIZNNXWQWCKIB-UHFFFAOYSA-N 0.000 claims description 2
- NDAUXUAQIAJITI-UHFFFAOYSA-N albuterol Chemical group CC(C)(C)NCC(O)C1=CC=C(O)C(CO)=C1 NDAUXUAQIAJITI-UHFFFAOYSA-N 0.000 claims description 2
- 229960001022 fenoterol Drugs 0.000 claims description 2
- OEXHQOGQTVQTAT-JRNQLAHRSA-N ipratropium Chemical group O([C@H]1C[C@H]2CC[C@@H](C1)[N@@+]2(C)C(C)C)C(=O)C(CO)C1=CC=CC=C1 OEXHQOGQTVQTAT-JRNQLAHRSA-N 0.000 claims description 2
- 229960001888 ipratropium Drugs 0.000 claims description 2
- 239000003380 propellant Substances 0.000 claims description 2
- 229960002052 salbutamol Drugs 0.000 claims description 2
- 229960004017 salmeterol Drugs 0.000 claims description 2
- 229960000195 terbutaline Drugs 0.000 claims description 2
- LERNTVKEWCAPOY-DZZGSBJMSA-N tiotropium Chemical compound O([C@H]1C[C@@H]2[N+]([C@H](C1)[C@@H]1[C@H]2O1)(C)C)C(=O)C(O)(C=1SC=CC=1)C1=CC=CS1 LERNTVKEWCAPOY-DZZGSBJMSA-N 0.000 claims description 2
- 229940110309 tiotropium Drugs 0.000 claims description 2
- 239000003814 drug Substances 0.000 abstract description 4
- 208000023504 respiratory system disease Diseases 0.000 abstract description 3
- 239000004480 active ingredient Substances 0.000 description 15
- 239000000443 aerosol Substances 0.000 description 9
- 150000001875 compounds Chemical class 0.000 description 6
- 229960002848 formoterol Drugs 0.000 description 6
- 239000003795 chemical substances by application Substances 0.000 description 5
- BPZSYCZIITTYBL-UHFFFAOYSA-N formoterol Chemical compound C1=CC(OC)=CC=C1CC(C)NCC(O)C1=CC=C(O)C(NC=O)=C1 BPZSYCZIITTYBL-UHFFFAOYSA-N 0.000 description 5
- 239000000843 powder Substances 0.000 description 5
- 238000002560 therapeutic procedure Methods 0.000 description 4
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 description 3
- 239000002253 acid Substances 0.000 description 3
- 239000008101 lactose Substances 0.000 description 3
- CURLTUGMZLYLDI-UHFFFAOYSA-N Carbon dioxide Chemical compound O=C=O CURLTUGMZLYLDI-UHFFFAOYSA-N 0.000 description 2
- 241000282412 Homo Species 0.000 description 2
- OIRDTQYFTABQOQ-KQYNXXCUSA-N adenosine Chemical compound C1=NC=2C(N)=NC=NC=2N1[C@@H]1O[C@H](CO)[C@@H](O)[C@H]1O OIRDTQYFTABQOQ-KQYNXXCUSA-N 0.000 description 2
- 239000000556 agonist Substances 0.000 description 2
- 239000003513 alkali Substances 0.000 description 2
- 239000008135 aqueous vehicle Substances 0.000 description 2
- 125000003118 aryl group Chemical group 0.000 description 2
- 206010006451 bronchitis Diseases 0.000 description 2
- 239000000337 buffer salt Substances 0.000 description 2
- 239000000969 carrier Substances 0.000 description 2
- 150000002148 esters Chemical class 0.000 description 2
- 208000030603 inherited susceptibility to asthma Diseases 0.000 description 2
- 210000004072 lung Anatomy 0.000 description 2
- 239000002245 particle Substances 0.000 description 2
- 238000009097 single-agent therapy Methods 0.000 description 2
- 239000007921 spray Substances 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- 125000004169 (C1-C6) alkyl group Chemical group 0.000 description 1
- DDMOUSALMHHKOS-UHFFFAOYSA-N 1,2-dichloro-1,1,2,2-tetrafluoroethane Chemical compound FC(F)(Cl)C(F)(F)Cl DDMOUSALMHHKOS-UHFFFAOYSA-N 0.000 description 1
- SJJCQDRGABAVBB-UHFFFAOYSA-N 1-hydroxy-2-naphthoic acid Chemical class C1=CC=CC2=C(O)C(C(=O)O)=CC=C21 SJJCQDRGABAVBB-UHFFFAOYSA-N 0.000 description 1
- LNETULKMXZVUST-UHFFFAOYSA-N 1-naphthoic acid Chemical compound C1=CC=C2C(C(=O)O)=CC=CC2=C1 LNETULKMXZVUST-UHFFFAOYSA-N 0.000 description 1
- PDNHLCRMUIGNBV-UHFFFAOYSA-N 1-pyridin-2-ylethanamine Chemical compound CC(N)C1=CC=CC=N1 PDNHLCRMUIGNBV-UHFFFAOYSA-N 0.000 description 1
- KUVIULQEHSCUHY-XYWKZLDCSA-N Beclometasone Chemical compound C1CC2=CC(=O)C=C[C@]2(C)[C@]2(Cl)[C@@H]1[C@@H]1C[C@H](C)[C@@](C(=O)COC(=O)CC)(OC(=O)CC)[C@@]1(C)C[C@@H]2O KUVIULQEHSCUHY-XYWKZLDCSA-N 0.000 description 1
- 206010006448 Bronchiolitis Diseases 0.000 description 1
- 206010006458 Bronchitis chronic Diseases 0.000 description 1
- 239000002126 C01EB10 - Adenosine Substances 0.000 description 1
- 108010059108 CD18 Antigens Proteins 0.000 description 1
- 239000004338 Dichlorodifluoromethane Substances 0.000 description 1
- 206010014561 Emphysema Diseases 0.000 description 1
- VZCYOOQTPOCHFL-OWOJBTEDSA-N Fumaric acid Chemical class OC(=O)\C=C\C(O)=O VZCYOOQTPOCHFL-OWOJBTEDSA-N 0.000 description 1
- 108010010803 Gelatin Proteins 0.000 description 1
- 102100029438 Nitric oxide synthase, inducible Human genes 0.000 description 1
- 101710089543 Nitric oxide synthase, inducible Proteins 0.000 description 1
- 229940123932 Phosphodiesterase 4 inhibitor Drugs 0.000 description 1
- 229920002472 Starch Polymers 0.000 description 1
- 102000001400 Tryptase Human genes 0.000 description 1
- 108060005989 Tryptase Proteins 0.000 description 1
- 229960005305 adenosine Drugs 0.000 description 1
- 125000000217 alkyl group Chemical group 0.000 description 1
- 150000001398 aluminium Chemical class 0.000 description 1
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 description 1
- 239000004411 aluminium Substances 0.000 description 1
- 229910052782 aluminium Inorganic materials 0.000 description 1
- 239000005030 aluminium foil Substances 0.000 description 1
- -1 amino acid ester Chemical class 0.000 description 1
- 239000005557 antagonist Substances 0.000 description 1
- 229940121363 anti-inflammatory agent Drugs 0.000 description 1
- 239000002260 anti-inflammatory agent Substances 0.000 description 1
- 239000004599 antimicrobial Substances 0.000 description 1
- 239000003963 antioxidant agent Substances 0.000 description 1
- 235000006708 antioxidants Nutrition 0.000 description 1
- 239000007864 aqueous solution Substances 0.000 description 1
- 239000007900 aqueous suspension Substances 0.000 description 1
- 239000002585 base Substances 0.000 description 1
- 229950000210 beclometasone dipropionate Drugs 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 239000002775 capsule Substances 0.000 description 1
- 229910002092 carbon dioxide Inorganic materials 0.000 description 1
- 239000001569 carbon dioxide Substances 0.000 description 1
- 208000007451 chronic bronchitis Diseases 0.000 description 1
- 230000001684 chronic effect Effects 0.000 description 1
- 229960001334 corticosteroids Drugs 0.000 description 1
- 229960000265 cromoglicic acid Drugs 0.000 description 1
- PXBRQCKWGAHEHS-UHFFFAOYSA-N dichlorodifluoromethane Chemical compound FC(F)(Cl)Cl PXBRQCKWGAHEHS-UHFFFAOYSA-N 0.000 description 1
- 235000019404 dichlorodifluoromethane Nutrition 0.000 description 1
- 229940042935 dichlorodifluoromethane Drugs 0.000 description 1
- 229940087091 dichlorotetrafluoroethane Drugs 0.000 description 1
- VLARUOGDXDTHEH-UHFFFAOYSA-L disodium cromoglycate Chemical compound [Na+].[Na+].O1C(C([O-])=O)=CC(=O)C2=C1C=CC=C2OCC(O)COC1=CC=CC2=C1C(=O)C=C(C([O-])=O)O2 VLARUOGDXDTHEH-UHFFFAOYSA-L 0.000 description 1
- 208000035475 disorder Diseases 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 230000002500 effect on skin Effects 0.000 description 1
- 239000003602 elastase inhibitor Substances 0.000 description 1
- 238000001914 filtration Methods 0.000 description 1
- 239000010419 fine particle Substances 0.000 description 1
- 229960000289 fluticasone propionate Drugs 0.000 description 1
- WMWTYOKRWGGJOA-CENSZEJFSA-N fluticasone propionate Chemical compound C1([C@@H](F)C2)=CC(=O)C=C[C@]1(C)[C@]1(F)[C@@H]2[C@@H]2C[C@@H](C)[C@@](C(=O)SCF)(OC(=O)CC)[C@@]2(C)C[C@@H]1O WMWTYOKRWGGJOA-CENSZEJFSA-N 0.000 description 1
- 239000011888 foil Substances 0.000 description 1
- 229920000159 gelatin Polymers 0.000 description 1
- 239000008273 gelatin Substances 0.000 description 1
- 239000007903 gelatin capsule Substances 0.000 description 1
- 235000019322 gelatine Nutrition 0.000 description 1
- 235000011852 gelatine desserts Nutrition 0.000 description 1
- 238000010438 heat treatment Methods 0.000 description 1
- 125000002887 hydroxy group Chemical group [H]O* 0.000 description 1
- 239000003112 inhibitor Substances 0.000 description 1
- 238000007918 intramuscular administration Methods 0.000 description 1
- 238000001990 intravenous administration Methods 0.000 description 1
- 239000003199 leukotriene receptor blocking agent Substances 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 150000007522 mineralic acids Chemical class 0.000 description 1
- 229960002744 mometasone furoate Drugs 0.000 description 1
- WOFMFGQZHJDGCX-ZULDAHANSA-N mometasone furoate Chemical compound O([C@]1([C@@]2(C)C[C@H](O)[C@]3(Cl)[C@@]4(C)C=CC(=O)C=C4CC[C@H]3[C@@H]2C[C@H]1C)C(=O)CCl)C(=O)C1=CC=CO1 WOFMFGQZHJDGCX-ZULDAHANSA-N 0.000 description 1
- 229960002259 nedocromil sodium Drugs 0.000 description 1
- 239000000041 non-steroidal anti-inflammatory agent Substances 0.000 description 1
- 229940021182 non-steroidal anti-inflammatory drug Drugs 0.000 description 1
- 239000002687 nonaqueous vehicle Substances 0.000 description 1
- 150000007524 organic acids Chemical class 0.000 description 1
- 239000002587 phosphodiesterase IV inhibitor Substances 0.000 description 1
- 230000035790 physiological processes and functions Effects 0.000 description 1
- 230000003389 potentiating effect Effects 0.000 description 1
- 238000007493 shaping process Methods 0.000 description 1
- 239000007787 solid Substances 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
- 239000008107 starch Substances 0.000 description 1
- 235000019698 starch Nutrition 0.000 description 1
- 238000007920 subcutaneous administration Methods 0.000 description 1
- 239000000725 suspension Substances 0.000 description 1
- 229940124597 therapeutic agent Drugs 0.000 description 1
- 239000002562 thickening agent Substances 0.000 description 1
- 230000000699 topical effect Effects 0.000 description 1
- 229960002117 triamcinolone acetonide Drugs 0.000 description 1
- YNDXUCZADRHECN-JNQJZLCISA-N triamcinolone acetonide Chemical compound C1CC2=CC(=O)C=C[C@]2(C)[C@]2(F)[C@@H]1[C@@H]1C[C@H]3OC(C)(C)O[C@@]3(C(=O)CO)[C@@]1(C)C[C@@H]2O YNDXUCZADRHECN-JNQJZLCISA-N 0.000 description 1
- CYRMSUTZVYGINF-UHFFFAOYSA-N trichlorofluoromethane Chemical compound FC(Cl)(Cl)Cl CYRMSUTZVYGINF-UHFFFAOYSA-N 0.000 description 1
- 229940029284 trichlorofluoromethane Drugs 0.000 description 1
- 239000002750 tryptase inhibitor Substances 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/007—Pulmonary tract; Aromatherapy
- A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
- A61K9/0075—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/58—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/007—Pulmonary tract; Aromatherapy
- A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
- A61K9/008—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy comprising drug dissolved or suspended in liquid propellant for inhalation via a pressurized metered dose inhaler [MDI]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/06—Antiasthmatics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
Definitions
- the present invention is concerned with combinations of (R,R)-formoterol and budesonide, particularly compositions containing a combination of (R,R)- formoterol and budesonide and the use of such compositions in medicine, particularly in the prophylaxis and treatment of respiratory diseases.
- Formoterol i.e. 2'-hydroxy-5'-[(RS)-1-hydroxy-2 ⁇ [(RS)-p-methoxy- ⁇ - methylphenethyl]amino ⁇ ethyl]formanilide, particularly its fumarate salt is a well- known adrenoreceptor agonist which is now used clinically in the treatment of bronchial asthma and related disorders.
- Formoterol includes two asymmetric centres and in a particular form exists as the (R,R)- isomer.
- the (R,R) isomer of formoterol has been described previously, for example, in WO98/21175 and US5795564.
- budesonide i.e. (11 ⁇ ,16 ⁇ )-16,17- [butylidenebis(oxy)]-11 ,21-dihydroxypregna-1 ,4-diene-3,20-dione, salts thereof and pharmaceutical formulations thereof.
- Budesonide is an antiinflammatory corticosteroid, which is now used clinically in the treatment of bronchial asthma and related disorders.
- WO 93/11773 describes combinations of budesonide and formoterol but is silent as to the utility of (R.R)-formoterol.
- a combination of (R.R)-formoterol or a pharmaceutically acceptable salt, solvate, or physiologically functional derivative thereof and budesonide or a pharmaceutically acceptable salt, solvate, or physiologically functional derivative thereof may be administered simultaneously, either in the same or different pharmaceutical formulations or sequentially. If there is sequential administration, the delay in administering the second compound should not be such as to lose the beneficial therapeutic effect of the combination.
- a pharmaceutical formulation comprising (R,R)-formoterol or a pharmaceutically acceptable salt, solvate, or physiologically functional derivative thereof and budesonide or a pharmaceutically acceptable salt, solvate, or physiologically functional derivative thereof, and a pharmaceutically acceptable carrier or excipient, and optionally one or more other therapeutic ingredients.
- a pharmaceutical formulation comprising (R,R)-formoterol fumarate and budesonide, and a pharmaceutically acceptable carrier or excipient, and optionally one or more other therapeutic ingredients.
- the above pharmaceutical formulations are suitable for administration by inhalation.
- physiologically functional derivative is meant a chemical derivative of (R,R)-formoterol or budesonide having the same physiological function as the free compound, for example, by being convertible in the body thereto.
- physiologically functional derivatives include esters.
- Suitable salts according to the invention include those formed with both organic and inorganic acids.
- Pharmaceutically acceptable acid addition salts include but are not limited to those formed from hydrochloric, hydrobromic, sulphuric, citric, . tartaric, phosphoric, lactic, pyruvic, acetic, trifluoroacetic, succinic, oxalic, fumaric, maleic, oxaloacetic, methanesulphonic, ethanesulphonic, p- toluenesulphonic, benzenesulphonic, isethionic, and naphthalenecarboxylic, such as 1-hydroxy-2-naphthalenecarboxylic acids.
- esters of (R,R)-formoterol or budesonide may have a hydroxyl group converted to a C 1-6 alkyl, aryl, aryl C- ⁇ - 6 alkyl, or amino acid ester.
- the present invention provides a method for the prophylaxis or treatment of a clinical condition in a mammal, such as a human, for which a selective ⁇ 2 -adrenoreceptor agonist and/or antiinflammatory corticosteroid is indicated, which comprises administration of a therapeutically effective amount of a combination of (R,R)-formoterol or a pharmaceutically acceptable salt, solvate, or physiologically functional derivative thereof and budesonide or a pharmaceutically acceptable salt, solvate, or physiologically functional derivative thereof.
- the present invention further provides a method for the prophylaxis or treatment of a clinical condition in a mammal, such as a human, for which a selective ⁇ 2 -adrenoreceptor agonist and/or antiinflammatory corticosteroid is indicated, which comprises administration of a therapeutically effective amount of a pharmaceutical formulation comprising (R,R)-formoterol or a pharmaceutically acceptable salt, solvate, or physiologically functional derivative thereof and budesonide or a pharmaceutically acceptable salt, solvate, or physiologically functional derivative thereof, and a pharmaceutically acceptable carrier or excipient.
- a pharmaceutical formulation comprising (R,R)-formoterol or a pharmaceutically acceptable salt, solvate, or physiologically functional derivative thereof and budesonide or a pharmaceutically acceptable salt, solvate, or physiologically functional derivative thereof, and a pharmaceutically acceptable carrier or excipient.
- a method which comprises administration of a therapeutically effective amount of a pharmaceutical formulation comprising (R,R)-formoterol fumarate and budesonide, and a pharmaceutically acceptable carrier or excipient.
- a pharmaceutical formulation comprising (R,R)-formoterol fumarate and budesonide, and a pharmaceutically acceptable carrier or excipient.
- the present invention provides such methods for the prophylaxis or treatment of a disease associated with reversible airways obstruction such as asthma, chronic obstructive pulmonary disease (COPD), respiratory tract infection or upper respiratory tract disease.
- COPD chronic obstructive pulmonary disease
- a pharmaceutical formulation comprising (R,R)- formoterol or a pharmaceutically acceptable salt, solvate, or physiologically functional derivative thereof (suitably, (R,R)-formoterol fumarate) and budesonide or a pharmaceutically acceptable salt, solvate, or physiologically functional derivative thereof, and a pharmaceutically acceptable carrier or excipient for use in therapy, particularly for use in the prophylaxis or treatment of a clinical condition for which a selective ⁇ 2 -adrenoreceptor agonist and/or antiinflammatory corticosteroid is indicated.
- the invention is concerned with the prophylaxis or treatment of a disease associated with reversible airways obstruction such as asthma, chronic obstructive pulmonary disease (COPD), respiratory tract infection or upper respiratory tract disease.
- COPD chronic obstructive pulmonary disease
- (R,R)-formoterol and budesonide or a pharmaceutically acceptable salt, solvate or physiologically functional derivative thereof which is required to achieve a therapeutic effect will, of course, vary with the particular compound, the route of administration, the subject under treatment, and the particular disorder or disease being treated.
- (R,R)-formoterol fumarate is generally administered to adult humans by aerosol inhalation at a dose of 12mcg or 24mcg twice daily.
- budesonide is generally administered to adult humans by aerosol inhalation at a dose of from i 200mcg to 1.6mg daily, taken as 2 divided doses:
- the active ingredients of the combination While it is possible for the active ingredients of the combination to be administered as the raw chemical, it is preferable to present them as a pharmaceutical formulation.
- the individual compounds of the combination When the individual compounds of the combination are administered separately, they are generally each presented as a pharmaceutical formulation as described previously in the art.
- Patient packs have an advantage over traditional prescriptions, where a pharmacist divides a patient's supply of a pharmaceutical from a bulk supply, in that the patient always has access to the package insert contained in the patient pack, normally missing in traditional prescriptions.
- the inclusion of a package insert has been shown to improve patient compliance with the physician's instructions and, therefore, lead generally to more successful treatment. It will be understood that the administration of the combination of the invention by means of a single patient pack, or patient packs of each component compound, and " containing a package insert instructing the patient to the correct use of the invention is a desirable additional feature of the invention.
- active ingredients means (R,R)-formoterol or a pharmaceutically acceptable salt, solvate, or physiologically functional derivative thereof, preferably (R,R)-formoterol fumarate, and budesonide, or a pharmaceutically acceptable salt, solvate, or physiologically functional derivative thereof.
- the pharmaceutical formulations which are suitable for inhalation according to the invention comprise the active ingredients in amounts such that each actuation provides therapeutically effective dose, for example, a dose of (R,R)-formoterol of 10mcg to 150mcg, preferably 24mcg and a dose of budesonide of 100mcg to 1.6mg, preferably 200mcg to 1mg, more preferably, 200mcg to 400mcg.
- a dose of (R,R)-formoterol of 10mcg to 150mcg, preferably 24mcg and a dose of budesonide of 100mcg to 1.6mg, preferably 200mcg to 1mg, more preferably, 200mcg to 400mcg.
- the pharmaceutical formulations according to the invention may further include other therapeutic agents for example anti-inflammatory agents such as other corticosteroids (e.g. fluticasone propionate, beclomethasone dipropionate, mometasone furoate, or triamcinolone acetonide), or NSAIDs (e.g.
- corticosteroids e.g. fluticasone propionate, beclomethasone dipropionate, mometasone furoate, or triamcinolone acetonide
- NSAIDs e.g.
- ⁇ 2 -adrenoreceptor agonists such as salbutamol, salmeterol, fenoterol or terbutaline and salts thereof
- anticholinergic agents such as ipratropium, or tiotropium
- the formulations include those suitable for oral, parenteral (including subcutaneous, intradermal, intramuscular, intravenous and intraarticular), intranasal, inhalation (including fine particle dusts or mists which may be generated by means of various types of metered dose pressurised aerosols, nebulisers or insufflators), rectal and topical (including dermal, buccal, sublingual and intraocular) administration although the most suitable route may depend upon for example the condition and disorder of the recipient.
- the formulations may conveniently be presented in unit dosage form and may be prepared by any of the methods well known in the art of pharmacy. All methods include the step of bringing the active ingredients into association with the carrier which constitutes one or more accessory ingredients. In general the formulations are prepared by uniformly and intimately bringing into association the active ingredients with liquid carriers or finely divided solid carriers or both and then, if necessary, shaping the product into the desired formulation.
- Formulations for inhalation include powder compositions which will preferably, contain lactose, and spray compositions which may be formulated, for example, as aqueous solutions or suspensions or as aerosols delivered from pressurised packs, with the use of a suitable propellant, e.g. dichlorodifluoromethane, trichlorofluoromethane, dichlorotetrafluoroethane, 1 ,1 ,1 ,2,3,3,3- heptafluoropropane, 1,1 ,1 ,2-tetrafluoroethane, carbon dioxide or other suitable gas.
- Suitable aerosol formulations include those described in EP 0372777 and WO93/11743.
- the active ingredients should be micronised so as to permit inhalation of substantially all of the active ingredients into the lungs upon administration of the aerosol formulation, thus the active ingredients will have a particle size of. less than 100 microns, desirably less than 20 microns, and preferably in the range 1 to 10 microns, for example, 1 to 5 microns.
- Intranasal sprays may be formulated with aqueous or non-aqueous vehicles with the addition of agents such as thickening agents, buffer salts or acid or alkali to adjust the pH, isotonicity adjusting agents or anti-oxidants.
- Capsules and cartridges or for example gelatin, or blisters of for example laminated aluminium foil, for use in an inhaler or insuflator may be formulated containing, a powder mix of the active ingredients and a suitable powder base such as lactose or starch.
- the active ingredients are suitably micronised so as to permit inhalation of substantially all of the active ingredients into the lungs upon administration of the dry powder formulation, thus the active ingredients will have a particle size of less than 100 microns, desirably less than 20 microns, and preferably in the range 1 to 10 microns.
- Solutions for inhalation by nebulation may be formulated with an aqueous vehicle with the addition of agents such as acid or alkali, buffer salts, isotonicity adjusting agents or antimicrobials. They may be sterilised by filtration or heating in an autoclave, or presented as a non-sterile product.
- Preferred unit dosage formulations are those containing a pharmaceutically effective dose, as hereinbefore recited, or an- appropriate fraction thereof, of the active ingredient.
- a pharmaceutically effective dose as hereinbefore recited, or an- appropriate fraction thereof, of the active ingredient.
- one actuation of the aerosol may deliver half of the therapeutically effective amount such that two actuations are necessary to deliver the therapeutically effective dose.
- formulations of this invention may include other agents conventional in the art having regard to the type of formulation in question.
- claimed formulations include bioequivalents as defined by the US Food and Drugs Agency.
- micronised active ingredients are weighed into an aluminium can, 1 ,1 ,1 ,2- tetrafluoroethane is then added from a vacuum flask and a metering valve is crimped into place.
- the active ingredients are micronised and bulk blended with the lactose in the proportions given above.
- the blend is filled into hard gelatin capsules or cartridges or in specifically constructed double foil blister packs to be administered by an inhaler such as a Rotahaler, Diskhaler, or Diskus inhaler (each of these being a Trademark of Glaxo Group Limited).
Abstract
Description
Claims
Priority Applications (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP2001576037A JP2004500430A (en) | 2000-04-18 | 2001-04-11 | Pharmaceutical combination containing formoterol and budesonide |
AU46716/01A AU4671601A (en) | 2000-04-18 | 2001-04-11 | Medical combinations comprising formoterol and budesonide |
EP01919655A EP1274435A1 (en) | 2000-04-18 | 2001-04-11 | Medical combinations comprising formoterol and budesonide |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
GB0009584.4 | 2000-04-18 | ||
GBGB0009584.4A GB0009584D0 (en) | 2000-04-18 | 2000-04-18 | Pharmaceutical compositions |
Publications (1)
Publication Number | Publication Date |
---|---|
WO2001078737A1 true WO2001078737A1 (en) | 2001-10-25 |
Family
ID=9890173
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/GB2001/001628 WO2001078737A1 (en) | 2000-04-18 | 2001-04-11 | Medical combinations comprising formoterol and budesonide |
Country Status (6)
Country | Link |
---|---|
US (1) | US20030109510A1 (en) |
EP (1) | EP1274435A1 (en) |
JP (1) | JP2004500430A (en) |
AU (1) | AU4671601A (en) |
GB (1) | GB0009584D0 (en) |
WO (1) | WO2001078737A1 (en) |
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WO2002083113A2 (en) * | 2001-04-17 | 2002-10-24 | Dey, L.P. | Aerosol compositions containing formoterol and a steroid such as e.g. budesonide or fluticasone for delivery into the lungs via nebulization |
WO2003000241A2 (en) * | 2001-06-23 | 2003-01-03 | Boehringer Ingelheim Pharma Gmbh & Co. Kg | Novel pharmaceutical compositions based on anticholinergic agents, corticosteroids and betamimetic agents, for the treatment of inflammatory and/or obstructive respiratory tract diseases |
JP2003534273A (en) * | 2000-05-19 | 2003-11-18 | アストラゼネカ・アクチエボラーグ | New composition |
US6667344B2 (en) | 2001-04-17 | 2003-12-23 | Dey, L.P. | Bronchodilating compositions and methods |
WO2004045621A1 (en) * | 2002-11-15 | 2004-06-03 | Astrazeneca Ab | Process to minimize loss through adhesion to equipment surfaces |
WO2004110539A1 (en) | 2003-06-19 | 2004-12-23 | Microdrug Ag | Administration of medicinal dry powders |
WO2004110491A1 (en) * | 2003-06-19 | 2004-12-23 | Microdrug Ag | Combined doses |
EP1531866A1 (en) * | 2002-08-29 | 2005-05-25 | Cipla Ltd. | Pharmaceutical products and compositions comprising specific anticholinergic agents, beta-2 agonists and corticosteroids |
WO2007099329A2 (en) * | 2006-03-01 | 2007-09-07 | Breath Ltd | Nebulizer formulation |
WO2008102128A3 (en) * | 2007-02-19 | 2009-01-08 | Cipla Ltd | Pharmaceutical combinations of at least two bronchodilators or of a bronchodilator with a corticosteroid |
EP1545634A4 (en) * | 2002-08-21 | 2009-09-09 | Norton Healthcare Ltd | Method of preparing dry powder inhalation compositions |
US7759328B2 (en) | 2002-02-01 | 2010-07-20 | Astrazeneca Ab | Composition for inhalation |
US8075873B2 (en) | 2002-08-21 | 2011-12-13 | Norton Healthcare Limited | Method of preparing dry powder inhalation compositions |
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US20100291221A1 (en) * | 2009-05-15 | 2010-11-18 | Robert Owen Cook | Method of administering dose-sparing amounts of formoterol fumarate-budesonide combination particles by inhalation |
CA2962531C (en) * | 2014-10-08 | 2023-05-23 | Eratech S.R.L. | Composition comprising at least one dry powder obtained by spray drying to increase the stability of the formulation |
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Also Published As
Publication number | Publication date |
---|---|
JP2004500430A (en) | 2004-01-08 |
US20030109510A1 (en) | 2003-06-12 |
EP1274435A1 (en) | 2003-01-15 |
GB0009584D0 (en) | 2000-06-07 |
AU4671601A (en) | 2001-10-30 |
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